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Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th
Date:6/21/2009

ts) for those that received standard chemotherapy.

"It is gratifying that we are seeing more patients convert to complete remission after the initial assessment period with pixantrone compared to other agents. These additional late responders are likely to have a positive impact on analyses of progression free and overall survival and will be provided to the U.S. Food and Drug Administration during the 120-day update," stated James A. Bianco, M.D., Chief Executive Officer of CTI. "We plan to request priority review of the NDA from the FDA as we believe that pixantrone would provide patients and physicians with a compelling new option in treating this disease."

Review of Pixantrone Clinical Studies in Indolent non-Hodgkin's lymphoma

Additionally, data from two previously reported clinical trials investigating pixantrone combined with other agents in indolent NHL is being reviewed. In one trial, PIX 302, patients that received pixantrone plus rituximab achieved higher CR and ORR rates, (CR=35% (7 of 20 patients); ORR=75% (15 of 20 patients)) as well as a longer TTP (13.2 months) than those who only received rituximab alone (CR=11% (2 of 18 patients); ORR=33% (6 of 18 patients); TTP=8.1 months) in relapsed/refractory indolent NHL. In a separate study, AZA I06, pixantrone and the FPD-R regimen achieved high response rates (CR/CRu=70% (19 of 27 patients); ORR=89% (24 of 27 patients) in relapsed/refractory indolent NHL, nearly all of whom had received aggressive first-line therapy with CHOP-R.

The Pan Pacific Lymphoma Conference poster is available at http://www.celltherapeutics.com/investor_updates.

About the PIX 301 EXTEND Trial

The PIX 301 EXTEND trial was a phase III single-agent trial of pixantrone for patients with relapsed or refractory, aggressive NHL who received two or more
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SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
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